BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 13218969 · Received January 11, 2022

    Report

    Report Number
    2028159-2022-00042
    Event Type
    Injury
    Date Received
    January 11, 2022
    Date of Event
    December 30, 2021
    Report Date
    May 26, 2022
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    OOE
    UDI-DI
    00380659981623
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A NON-CONFORMANCE-BASED REVIEW OF THE BATCH/LOT/SERIAL NUMBER WAS PERFORMED AND DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT. A MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. THE CUSTOMER REPORTED THE ¿DOCTOR COULD NOT OPEN FLAP EASILY¿ SERVICE HISTORY WAS REVIEWED FOR THE SYSTEM. THERE WAS NO SERVICE RECORD, (RELEVANT TO THE REPORTED EVENT) FOUND. HOWEVER, THE SYSTEM WAS SERVICED PRIOR TO THE REPORTED EVENT. THE SYSTEM WAS FOUND TO MEET ALL COSMETIC AND PERFORMANCE STANDARDS AT THAT TIME. DEBRIS WAS CLEANED FROM THE OBJECTIVE, AS PART OF SERVICING. IT REMAINS INCONCLUSIVE WHEN OR HOW THE DEBRIS BECAME PRESENT ON THE OBJECTIVE. WITH CURRENT INFORMATION, IT REMAINS INCONCLUSIVE WHETHER THIS FINDING ON THE OBJECTIVE CONTRIBUTED TO ANY NONCONFORMITY WHILE USING THE LASER. THERE IS NO INFORMATION PROVIDED TO CONCLUSIVELY INDICATE NONCONFORMANCE OF THE LASER CONTRIBUTED TO THE REPORTED EVENT. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS LOT/BATCH/SERIAL NUMBER WAS PERFORMED. POTENTIALLY RELEVANT COMPLAINTS WERE FOUND AND REVIEWED AS PART OF THIS INVESTIGATION. THE COMPLAINTS FOR SIMILAR PREVIOUS REPORTS WERE ALL ADDRESSED BY A SINGLE SERVICE RECORD, IN WHICH THE COMPANY REPRESENTATIVE FOUND LIQUID RESIDUE ON THE OUTPUT LENS OF THE OBJECTIVE, AS WELL AS A NONCONFORMITY IN THE XY CALIBRATION FOR FLAP MODE. AS CORRECTIONS, THE COMPANY REPRESENTATIVE REMOVED THE LIQUID RESIDUE FROM THE FACE OF THE OBJECTIVE LENS AND CALIBRATED THE XY CALIBRATION FOR FLAP MODE. AS PREVENTIVE MEASURES, THE COMPANY REPRESENTATIVE OPTIMIZED THE SPOT SIZE IN FLAP MODE, VERIFIED THE Z DEPTH CALIBRATION IN FLAP MODE, AND CALIBRATED THE APPLANATION. THE COMPANY REPRESENTATIVE PERFORMED SEVERAL MOCK SURGERIES IN FLAP AND CATARACT MODE SUCCESSFULLY. THE SYSTEM WAS THEN TESTED AND FOUND TO MEET SPECIFICATION. THE COMPLAINTS ASSOCIATED WITH THIS SERVICING ULTIMATELY HAD INCONCLUSIVE ROOT CAUSE BASED ON THE INFORMATION AVAILABLE. BASED ON THE INFORMATION AVAILABLE, NO SYSTEM NONCONFORMITY WHICH MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED EVENT CAN BE CONFIRMED. THUS, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED DURING FLAP CREATION, FLAP COULD NOT OPEN EASILY AFTER LASER FIRED AND FORCE USED TO OPEN IT. LIKE IT WAS GLUED WITH STROMA. STROMA WAS VISIBLE WITH WHITE COLORED TISSUE AND HAD VISIBLE DENT IN THIS AREA AFTER OPENING OF FLAP. THE DOCTOR DESCRIBE THIS CHANGE THAT LOOKS LIKE IN PATIENT WHO HAS ULCUS. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. AT THE END FLAP WAS SUCCESSFULLY OPENED AND OPERATION WAS COMPLETED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESS PATIENT SV RIGHT EYE AND OTHER MANUFACTURED REPORTS WILL BE FILED. ADDITIONAL INFORMATION RECEIVED. DOCTOR USED SPATULA TO OPEN THE FLAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644183 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention